Title:Thrombosis and Hemostasis Centers Research and Prevention Network (U01)

The policies, guidelines, terms, and conditions of the HHS
Centers for Disease Control and Prevention (CDC) stated in this announcement
may differ from those used by the HHS National Institutes of Health (NIH). If
a CDC policy does not exist to cover an applicable topic, or is in the process
of being drafted, then for purposes of this announcement, the NIH policy is
hereby adopted by CDC and will be applicable to that particular topic. In
addition, if written guidance for completing this application is not available
on the CDC website, then applicants will be directed elsewhere for that
information.

Authority:This program is authorized under
Sections 311,317(k)(2) and 317 (C) of the Public Health Service Act., (42
U.S.C., Section 243, 247b(k)(2) and 247b-4) as
amended.

Announcement
Type:
New

Instructions for Submission of Electronic Research
Applications:

NOTICE: Applications submitted in
response to this Funding Opportunity Announcement (FOA) for Federal assistance
must be submitted electronically through
Grants.gov using the SF424 Research and Related (R&R) forms and the SF424
(R&R) Application Guide.

This FOA must be read in conjunction with the application
package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter
referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and
applicants are highly encouraged to start the process at least four weeks prior
to the grant submission date. See Section IV.

Two steps are
required for on time submission:

1) The application
must be successfully received by Grants.gov no later than 5:00 p.m.Eastern
Standard Time on the application submission receipt date (see “Key Dates”
below).

2) Applicants must
complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of
notification. Note: Since e-mail can be unreliable, it is the responsibility
of the applicant to periodically check on their application status in the eRA Commons.

Thepurpose
of this research announcement is to
provide support to two
organizations to join four projects previously funded under CDC Announcements 1085 and
04013: Integrating of Prevention Services of Persons with Bleeding and
Clotting Disorders. During the previous two project periods,(announced under FOA DD07-004) four
sites: (1) established
a network of Thrombosis and Hemostasis Centers were to
investigate and elucidate a model of care for thrombosis and its
complications including characteristics of both the patient population and
the thrombosis centers themselves; (2) developed study
protocols and informed consent forms, approved by CDC and the individual site Institutional Review Boards
(IRBs); (3) implemented a web
based Thrombosis and Hemostasis Centers Patient Registry and initiated data collection; (4) defined the
characteristics of a Thrombosis and Hemostasis Center and described the
patients served; and (5) began to explore the
needs and identify gaps in research of the Thrombosis and Thrombophilia
communities.

Awards
issued under this FOA are contingent upon the availability of funds and
the submission of a sufficient number of meritorious applications.

Anticipated number of awards to be
issued:Two

Budget
Period, Project Period, and Award Amounts: The
award of $250,000 for each project will be for a one year budget period
within a five year project period. The total funding level noted above
includes both direct and indirect costs.

Eligible
Investigators (PD/PIs): Any individual
with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an
application for support.

The NCBDDD of CDC
within HHS is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010" and to measuring
program performance as stipulated by the Government Performance and Review Act
(GPRA). This Funding Opportunity Announcement addresses “Healthy People
2010” priority area(s) of Maternal, Infant, and Child Health and Disability and
Secondary Conditions, and is in alignment with NCBDDD performance goal(s) to
prevent birth defects and developmental disabilities and improve
the health of people with disabilities. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

This announcement will focus upon patient
provider education, patient care, and continuation and the expansion of a registry to further epidemiologic and clinical research investigations in the
areas of thrombosis, thrombophilia, and the reduction and prevention of their
associated complications.

Venous thromboembolism, the third most common
cardiovascular disease after coronary artery disease and stroke, has an annual
incidence of about 1 per 1000 and is associated with significant morbidity and
mortality. Deep vein thrombosis (DVT) is a life-threatening event since a clot
can detach, travel to the lung, and occlude a major vessel. Pulmonary embolism
(PE), a frequent sequela to a deep-vein thrombosis (DVT), entails a 15% risk of
death, accounting for up to 100,000 fatalities per year. Other sequelae of DVT
include post-thrombotic syndrome, recurrent thrombosis, and complications of
anticoagulation therapy. Acquired factors which increase risk of VTE include
surgery, trauma, malignancy, immobilization and pregnancy. Deficiencies in
anticoagulant proteins C, S, or antithrombin III are responsible for less than
10% of cases of VTE.

Recently, researchers have identified numerous
polymorphisms in genes which code for components of the hemostatic system or
affect condition of the vessel wall. A defect in the factor V leads to a poor
response to the anticoagulant activated protein C (APC) and, as a result, a
thrombophilic state (Bertina, 1994). The factor V (Leiden) mutation has been
identified as a cause of DVT in several epidemiologic studies (Koster, 1993;
Svensson, 1994; Ridker, 1995) and has been shown to be strongly associated with
recurrence of venous thrombosis (Simioni, 1997). A second gene of potential
importance, associated with plasma levels of the coagulation factor,
prothrombin, involves a nucleotide change (a G to A transition) at position
20210 in the 3'-UT region of the prothrombin gene. The 20210 AG genotype has
been associated with a 3-fold increased risk of VTE in several epidemiologic
studies (Poort, 1996; Margaglione, 1998).

Pregnancy is by definition a prothrombotic
state, characterized by increased levels of fibrinogen, coagulation factors VII, VIII, and C, and von Willlebrand factor (vWF) as well as by decreased activity of protein S
(Walker, 1994; Letsky, 1994). In the presence of inherited thrombophilia, the
risk of thrombosis in pregnancy is greatly increased. Several recent studies
suggest that factor V Leiden and prothrombin G20210A mutations may be
associated with thrombosis during pregnancy (Dilley, 2000; Gerhardt, 2000). A
growing body of literature suggests that thrombophilia may play a role in other
adverse outcomes of pregnancy. Both recurrent fetal loss and IUGR may have
thrombogenic etiologies and result from compromise of placental vasculature (Preston, 1996). Factor V Leiden mutation, antiphospholipid antibodies, and deficiencies of
proteins C, S, and antithrombin III have been implicated in fetal loss.

Venous thromboembolism (VTE) is a common
disorder associated with significant morbidity and mortality. Despite
important advances in understanding the etiology of VTE, delivery of care to
patients with thrombosis and thrombophilia is frequently incomplete and highly
variable. A comprehensive model of health care has been used successfully to
treat and prevent complications for people with hemophilia and other chronic
disorders. The effectiveness of an integrated healthcare model for patients
with all coagulation disorders has yet to be evaluated.

The Division of Hereditary Blood Disorders,
NCBDDD of the Centers for Disease Control and Prevention (CDC) is collaborating
with Thrombosis and Hemostasis Centers (pilot sites) to provide health-related
services and conduct research directed toward the reduction or prevention of
complications of thrombosis and thrombophilia.

The Objectives/Goals
for this announcement and DD07-04 will be to:

Further the epidemiologic research capacity of
the centers by expanding upon the current Thrombosis and Hemostasis Centers
Patient Registry to include biological samples for the investigation of genetic
polymorphisms, plasma markers of thrombosis, inpatients, and family history.

Evaluate the clinical outcomes for patients longitudinally

Evaluate and measure quality
of life and patient
satisfaction.

Investigate, describe and further elucidate
the burden and treatment of thrombophilia and thrombosis in the pediatric and
maternal fetal medicine populations.

Describe current laboratory testing standards
for thrombosis and thrombophilia and assess the need for standardization of
laboratory testing and evaluation.

Contribute to the existing science by engaging
in prospective, epidemiologic studies of the established patient cohort.

Provide patient and provider education by
working closely with national patient organizations.

In
addition:

Recipients will work collaboratively with the sites funded under FOA DD07-04 and
NCBDDD to achieve the goals and objectives for the study. CDC will assist in
coordinating data and sample storage, as well as epidemiologic,
statistical and laboratory support.

Study data will be collected through the
Thrombosis and Hemostasis Centers Patient Registry. Sites will participate
fully in enrolling and entering patients into the registry. The existing
protocol from studies funded under FOA DD07-004 will be followed. All sites must have the necessary Institutional
Review Board (IRB) approvals of the protocol and consent
forms.

Each site will have one investigator on the
existing Coordinating Committee and at least one active participant on the established as well as new
subcommittees. Current subcommittees include: Data Subcommittee, Protocol
Subcommittee, Laboratory Subcommittee, and Education Subcommittee.

Study data will be analyzed by appropriate
statistical methods at CDC/NCBDDD.

All independent research analyses and
protocols for the use of study data or center network must be submitted in
writing to the Protocol Committee for review and
Coordinating Committee for final approval.

Under this announcement, funds will be awarded to two sites which best meet the criteria as stated under
the Eligibility Section of this announcement.

Outcomes for this research project include:

Establishing a research network for thrombosis
and thrombophilia. Sites will be considered successful by full participation
in the patient registry as demonstrated by a steady flow of data collection and
data entry into the registry; participating and following study protocols and
methods of all sub-studies; and participation in steering committee and
subcommittees.

Evaluating patient care. Sites will be
considered successful by participating fully in implemented protocols for
patient care, quality of life, and laboratory evaluation.

Improving patient education. Sites will be
considered successful by working closely with the Education subcommittee to
work on educational materials and participate in seminars as needed.

Adding to the scientific knowledge base on
thrombosis and thrombophilia.

Analyzing patient registry data to achieve
study objectives. Results of these analyses will be disseminated to the
medical community via published manuscripts and presentations (abstracts,
posters, and oral presentations) at scientific conferences and peer reviewed
journals. Educational materials in the form of patient and provider brochures
should also be developed as indicated.

As part of the required work plan, applicants
should outline the process wherein they will ensure that the application
includes a clear plan for enrollment of subjects; IRB/Health
Insurance Portability and Accountability Act (HIPAA)/Human
Subjects approvals; adequate and qualified personnel to manage the study,
identifying and enrolling patients; and collecting and entering data with a
full description of prior/current databases.

The HHS/CDC
U01 is a cooperative agreement assistance instrument. Under the U01 assistance
instrument, the Recipient Organization retains the primary responsibility and
dominant role for planning, directing, and executing the proposed project, and
with HHS/CDC staff being substantially involved as a partner with the Recipient
Organization as described in Section VI.2.A., Cooperative Agreement.

2. Funds
Available

The NCBDDD intends to commit approximately $500,000 that includes both direct and indirect
costs in FY 2007 to fundtwo awards for the first
12 month budget period. The applicant may request a project period of up to
five years. The approximate total project period funded amount for each funded
project is approximately $250,000. The anticipated start date for new awards is
July 1, 2007.

CDC will accept and review applications with budgets
greater than the ceiling amount. However, the award issued pursuant to this
funding opportunity is contingent upon the availability of funds.

Section
III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any
of the following characteristics:

Private nonprofit organizations

Universities

Colleges

Research institutions

Eligible organizations must present and demonstrate specific competencies
and capacities. To be eligible,applications
will be reviewed for responsiveness by the Office of
Extramural Research, OER, NCBDDD funding office in advance of the
formal merit review of applications to document that the evidence presented demonstrates that the applicant fully meet
the below eligibility requirements.

Provide evidence that the applicant is a medical
center with established thrombosis and hemostasis programs with a
multi-generational, multi-ethnic thrombosis and thrombophilia patient base, a
large referral base from outpatient sources, and collaborations in place with
cardiology, obstetrics and gynecology, neurology, rheumatology, interventional
radiology, and surgery.

Provide evidence that the Principal Investigator, key consultants or
subcontractors are a primary member of the Thrombosis and
Hemostasis clinic and demonstrates clinical research expertise
in the area of thrombosis and thrombophilia including diagnosis and management
of complex thrombotic disorders.

Provide evidence through letters of support that
the applicant has the ability to
collaborate with and enroll subjects from Pediatric Hematology and High Risk
Maternal and Fetal Medicine clinics.

Provides evidence that the operational clinic provides anticoagulation management or is
an integral part of the anticoagulation clinic.

To meet the above
eligibility requirements, the applicant should respond directly to these points in a separate section of
the application (not to exceed four pages). This information should be provided directly behind the face page of
the application and will be reviewed by OER,
NCBDDD as the basis for determining eligibility and for forwarding the
application to the formal scientific review committee. Please make sure if you need to include any of the
information again in your application you do so.

Since
this project will be funded for up to five years without further outside
competition, CDC feels it is critical that prospective applicants demonstrate
their experience, potential and prognosis for success by providing convincing
evidence of their experience and capabilities in addressing the major
objectives under the requirements of this announcement. The points
presented in the eligibility determination component of the application may be
expanded on, referred to, and redirected to the project narrative to address
the research objectives in this announcement and convey the capacity of the
applicant to fully be successful in achieving all aspects and components of
this research.

1.B. Eligible Investigators

Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for CDC programs.

2. Cost
Sharing or Matching

Cost Sharing, matching funds, or cost
participation is not required under this announcement. The most
current PHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/gps/

3. Other-Special
Eligibility Criteria

If your application
is incomplete or non-responsive to the special requirements listed in this
section, it will not enter into the review process.

Note: Title 2 of the
United States Code Section 1611 states that an organization described in
Section 501(c)(4) of the Internal Revenue Code that engages in lobbying
activities is not eligible to receive Federal funds constituting an award,
grant, or loan.

Section
IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Instructions for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A
one-time registration is required for institutions/organizations at the
following:

The individual designated as the PD/PI on the
application must also be registered in the eRA Commons. It is not
necessary for PDs/PIs to register with Grants.gov.

The PD/PI must hold a PD/PI account in the eRA
Commons and must be affiliated with the applicant organization. This
account cannot have any other role attached to it other than the PD/PI.

This registration/affiliation must be done by the
Authorized Organization Representative/Signing Official (AOR/SO) or their
designee who is already registered in the eRA Commons.

Both the PD/PI and AOR/SO need separate accounts in
the eRA Commons since both hold different roles for authorization and to
view the application process.

Note
that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR
registration, that particular DUNS number and CCR registration are for the
individual reviewer only. These are different than any DUNS number and CCR
registration used by an applicant organization. Individual DUNS and CCR
registration should be used only for the purposes of personal reimbursement and
should not be used on any grant applications submitted to the Federal
Government.

Several
of the steps of the registration process could take four weeks or more.
Therefore, applicants should immediately check with their business official to
determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC
strongly encourages applicants to use the Grants.gov electronic applications process and have
organizations and PD/PIs complete all necessary registrations.

1.
Request Application Information

Applicants
must download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply

Note: Only the forms package directly attached to a specific
FOA can be used. You will not be able to use any other SF424 (R&R) forms
(e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.

Prepare
all applications using the SF424 (R&R) application forms and in accordance
with the SF424
(R&R) Application Guide (MS Word or PDF).

The
SF424 (R&R) Application Guide is critical to submitting a complete and
accurate application to HHS/CDC. There are fields within the SF424 (R&R)
application components that, although not marked as mandatory, are required by
HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related
Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA
Commons User ID). Agency-specific instructions for such fields are clearly
identified in the Application Guide. For additional information, see “Tips and
Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The
SF424 (R&R) application is comprised of data arranged in separate
components. Some components are required, others are optional. The forms
package associated with this FOA in Grants.gov/APPLY will include all applicable
components, mandatory and optional. A completed application in response to
this FOA will include the following components:

Prospective applicants are asked to submit a
letter of intent that includes the following information:

Descriptive title of proposed research.

Name, address, and telephone number of the
Principal Investigator.

Names of other key personnel.

Participating institutions.

Number and title of this funding opportunity.

Although a letter of intent is not required,
is not binding, and does not enter into the review of a subsequent application,
the information that it contains allows CDC Program staff to estimate the
potential review workload and plan the review.

The letter of intent is to be sent by the date
listed in Section IV.3.A

If the instructions in this
announcement differ in any way from the 424 R&R instructions, follow the
instructions in this announcement.

To submit an application in response to this FOA,
applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is
done electronically through Grants.gov (http://www.grants.gov), the application will be
electronically time/date stamped by Grants.gov. Applicants will receive an
e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives
the application.

All requested information must be received in the HHS/CDC
Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the
deadline date. If an applicant submits materials by the United States Postal
Service or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery by the closing date and time. If HHS/CDC
receives your submission after closing because of : (1) carrier error, when the
carrier accepted the package with a guarantee for delivery by the closing date
and time, or (2) significant weather delays or natural disasters, you have the
opportunity to submit documentation of the carrier’s guarantee. If the
documentation verifies a carrier problem, HHS/CDC will consider the submission
as having been received by the deadline.

This announcement is the definitive guide on application
content, submission address, and deadline. It supersedes information provided
in the application instructions. If your application does not meet the
deadline described in Section IV.3.A, it will not be eligible for review, and
HHS/CDC will discard it. You will receive notification that you did not meet
the submission requirements.

Otherwise, HHS/CDC will not notify
you upon receipt of your paper submission. If you have a question about the
receipt of your application, first contact your courier. If you still have a
question, contact the PGO-TIMS staff at: 770-488-2700. Before calling, please
wait two to three days after the submission deadline. This will allow time for
HHS/CDC to process and log submissions.

If submitting a paper application,
it must be prepared using the 424 R&R instructions for preparing a research
grant application. Submit a signed, typewritten original of the application and
all appendices, including the checklist, and three signed photocopy(s) to the
following address:

HHS/CDC must receive applications on or
before 5:00 P.M. Eastern Time on the application submission date(s) described
above (Section IV.3.A.). If HHS/CDC receives an application after that
submission date and time, the application may be delayed in the review process
or not reviewed.

Once
an application package has been successfully submitted through Grants.gov, any
errors have been addressed, and the assembled application has been created in
the eRA Commons, the PD/PI and the Authorized Organization
Representative/Signing Official (AOR/SO) have two business days to view the
application image.

If everything is acceptable, no further action is
necessary. The application will automatically move forward for processing by
the CDC, PGO, Technical Information Management Section, after two business
days.

Prior to the submission deadline, the AOR/SO can “Reject”
the assembled application and submit a changed/corrected application within the
two day viewing window. This option should be used if the AOR/SO determines
that warnings should be addressed. Reminder: warnings do not stop further
application processing. If an application submission results in warnings (but
no errors) it will automatically move forward after two business days if no
action is taken. Please remember that some warnings may not be applicable or
may need to be addressed after application submission.

If the two day window falls after the submission deadline,
the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn’t
transfer correctly during the submission process). The AOR/SO should first
contact the eRA Commons Helpdesk to
confirm the system error, document the issue, and determine the best course of
action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject” the image after the
submission deadline for a reason other than an eRA Commons or Grants.gov system
failure, a changed/corrected application still can be submitted but it will be
subject to the CDC late policy guidelines and may not be accepted. The reason
for this delay should be explained in the cover letter attachment and must
refer only to Commons errors and/or technical errors.

Both the AOR/SO and PD/PI will receive e-mail
notifications when the application is rejected or the application automatically
moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness
and responsiveness by NCBDDD and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will
not review incomplete
and non-responsive applications.

There will be an acknowledgement of receipt of
applications from Grants.gov and the eRA Commons.

4.
Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All HHS/CDC awards are subject to
the terms and conditions, cost principles, and other considerations described
in the HHS/PHS Grants Policy Statement.

Additional guidance can be found
at HHS/PHS Grants Policy Statement.

Restrictions, which applicants
must take into account while writing their budgets, are as follows:

Funds relating to the conduct of research involving
human subjects will be restricted until the appropriate
assurances and Institutional Review Board approvals are in place.

6. Other Submission Requirements

Awardees upon acceptance of Notice of
Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions
of Award" in Section VI. "Award Administration Information”.

If you are requesting indirect costs in your budget, you
must include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12 months of
age. If submitting electronically, use a PDF version of the
agreement, attach it in Grants.gov under “Other Attachments,” and title it
appropriately.

Applicants’ research plan(s) should address activities
they will conduct over the entire project period.

The
HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the
“PROFILE – Project Director/Principal Investigator” section, “Credential”
log-in field of the “Research & Related Senior/Key Person Profile”
component. The applicant organization must include its DUNS number in its
Organization Profile in the eRA Commons. This DUNS number must match the DUNS
number provided at CCR registration with Grants.gov. For additional
information, see Registration FAQs – Important Tips – Electronic Submission of Grant
Applications.

Research
Plan Component Sections

While
each section of the Research Plan component needs to be uploaded separately as
a PDF attachment, applicants are encouraged to construct the Research Plan
component as a single document, separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits. All
attachments must be provided to HHS/CDC in PDF format, filenames must be
included with no spaces or special characters, and a
.pdf extension must be used. Do not include any information in a header or
footer of the attachments. A header will be system-generated that references
the PD/PI. Page numbers for the footer will be system-generated in the complete
application, with all pages sequentially numbered; therefore, do not number the
pages of your attachments. Your research plan must not exceed 25 pages.
If your research plan exceeds the page limitation, your application may be
considered unresponsive and ineligible for review. Information contained in
the appendix as noted below is not included in this page limitation.

The following
materials may be included in the Appendix:

Up to fifteen publications,
manuscripts (accepted for publication), abstracts, patents, or other
printed materials directly relevant to the proposed project. Do not include
manuscripts submitted for publication. Applicants should refer
to instruction guides and specific Funding Opportunity Announcements (FOAs) to
determine the appropriate limit on the number of publications that may be
submitted for a particular program. Note that not all grant activity codes
allow the inclusion of publications.

Publications in press: Include
only a publication list with a link to the publicly available on-line journal
article or the NIH PubMed Central (PMC) submission identification
number. Do not include the entire article.

Manuscripts accepted for publication but not yet
published: The entire article may be submitted
electronically as a PDF attachment.

Manuscripts published but a publicly available online
journal link is not available: The entire article
may be submitted electronically as a PDF attachment.

Graphic images of gels, micrographs, etc. provided that
the image (may be reduced in size) is also included within the (stated) page
limit of Items 2-5 of the Research Plan component. No images may be
included in the Appendix that are not also represented within the Research
Plan.

Do not to use the Appendix to circumvent
the page limitations of the Research Plan component. An application that does
not observe the relevant policies and procedures may not be
considered in the review process. Applicants are
reminded to review specific FOAs for any additional program-specific guidance
on Appendix material and other application requirements.

It is especially important that the abstract (Description,
PHS 398 form, page 2) of your application reflects the focus and purpose of the
overall application. That is important since If your application is funded,
your abstract will become public information. The language of the abstract
must be simple and easy to understand for a broad audience.

Plan
for Sharing Research Data

The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
should describe briefly the expected schedule for data sharing, the format of
the final dataset, the documentation they will provide, whether or not any
analytic tools also will be provided, whether or not a data-sharing agreement
will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not the awardee will place any conditions on their use), and the mode of data
sharing (e.g., under their own auspices by mailing a disk or posting data on
their institutional or personal website, through a data archive or enclave).
References to data sharing may also be appropriate in other sections of the
application.

Thus, the applicant must include a plan for sharing
research data in their application. The HHS/CDC data sharing policy is
available at http://www.cdc.gov/od/pgo/funding/ARs.htm under
Additional Requirements 25 Release and Sharing of Data. Investigators
responding to this funding opportunity should include a description of how
final research data will be shared, or explain why data sharing is not
possible.

The reasonableness
of the data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit of the application or
the priority score.

Sharing Research Resources

HHS/PHS policy requires that
grant award recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (see the HHS/PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.) Investigators responding to this funding
opportunity should include a plan for sharing research resources addressing how
unique research resources will be shared or explain why sharing is not
possible.

The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
the HHS/CDC Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590,http://grants.nih.gov/grants/funding/2590/2590.htm). See Section
VI.3. Reporting.

Section
V. Application Review Information

1.
Criteria

Only the review criteria described below will be
considered in the review process.

Scientific
merit of the proposed project as determined by peer review

Availability
of funds

Relevance
of program priorities and the priorities of the U.S. Department of Health
and Human Services

2.
Review and Selection Process

Applications
that are complete and responsive to the FOA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by the CDC
Office of Public Health Research (OPHR) in accordance with the review
criteria stated below.

As
part of the initial merit review, all applications will:

Undergo a selection process
in which only those applications deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed and assigned a priority score

Receive a written critique;
and

Receive a second level of
review by HHS/CDC NCBDDD

Applications submitted in
response to this FOA will compete for available funds with all other
eligible applications. The criteria listed in Section V.1. will be
considered in making funding decisions.

The goals
of HHS/CDC-supported research are to advance the understanding of health
promotion and the prevention of disease, injury, and disability, and enhance
preparedness. In the written comments, evaluate the application to judge the
likelihood the proposed research will have a substantial impact on the pursuit
of these goals. Each of these criteria will be addressed by the reviewers and
considered in assigning the overall score, weighting them and weighted, as
appropriate for each application:

Significance

Approach

Innovation

Investigators

Environment

Note that
an application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

Significance: Does
this study address an important problem? If the applicant achieves the aims of
the application, how will it advance scientific knowledge or clinical practice?
What will be the effect of these studies on the concepts, methods,
technologies, treatments, or preventative interventions that drive this field?

Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the
project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?

Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?

Environment: Does the scientific
environment in which the applicant will do the work contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?

2.A. Additional
Review Criteria

In
addition to the above criteria, the following items will be considered in the
determination of scientific merit and the priority score:

Each application should include at least one
research project relevant to the outcomes
and capable of being applied to the network.

Within the project narrative and to effectively
demonstrate all eligible applicants’ capacity to undertake and accomplish the
above clinical and research activities, applicants should include a
presentation of its current history and experience in addressing the major
activities under this research announcement. As such, that application should
incorporate an analysis of specific clinical and research tasks performed,
denote research conducted by itself and/or under funded sub-projects, outline
indications of scientific and management oversight competencies, and convey
evidence of effective performance based on published reports of research and
program outcomes with cited broad public health applications.

Protection of
Human Subjects from Research Risk: When human subjects are
involved, HHS/CDC will assess the available protections from research
risk that relate to their participation in the proposed research. [see the
Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under
AR-1 Human Subjects Requirements are available on the Internet at the
following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of
Women and Minorities in Research:

Does
the application adequately address the HHS/CDC Policy requirements regarding
the inclusion of women, ethnic, and racial groups in the proposed research?
This includes: (1) The proposed plan for the inclusion of both sexes and racial
and ethnic minority populations for appropriate representation; (2) The
proposed justification when representation is limited or absent; (3) A
statement as to whether the design of the study is adequate to measure
differences when warranted; and (4) A statement as to whether the plans for
recruitment and outreach for study participants include the process of
establishing partnerships with community(ies) and recognition of mutual
benefits (see Section 2, item 9 Inclusion or Women and Minorities of the
Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If
applicants plan to use vertebrate animals in the project, HHS/CDC will assess
the five items described under Section 2, item 12 Vertebrate Animals of the
Research Plan component of the SF424 (R&R). Additional HHS/CDC Requirements under AR-3 Animal
Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose materials
or procedures that are potentially hazardous to research personnel and/or the
environment, HHS/CDC will determine if the proposed protection is adequate.
2.B. Additional Review Considerations

Budget and Period of Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by the
reviewers. Is the number of person months listed for the effort of the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods? The evaluation of the budget
should not affect the priority score.

2.C. Sharing
Research Data

Data Sharing Plan: HHS/CDC
will assess the reasonableness of the data sharing plan. However, reviewers
will not factor the proposed data sharing plan into the determination of
scientific merit or the priority score. The presence of a data sharing plan
will be part of the terms and conditions of the award. The funding organization
will be responsible for monitoring the data sharing policy.

Reviewers
will be asked to assess the adequacy of the research sharing plan as proposed
in the application.

2.D. Sharing
Research Resources

HHS/ PHS policy requires that
recipients of grant awards make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication. Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.
Investigators responding to this funding opportunity should include a plan on
sharing research resources.

Reviewers
will be asked to assess the adequacy of the mechanism described for sharing
research resources as proposed in the application.

The
adequacy of the resources sharing plan will be considered by Program staff of
the funding organization when making recommendations about funding applications.
The effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (HHS/PHS 2590http://grants.nih.gov/grants/funding/2590/2590.htm). See Section
VI.3. Reporting

3.
Anticipated Announcement and Award Dates

The CDC
Procurement and Grants will notify successful applicants in a pre-award
conference call and by providing the notice
of award.

Section
VI. Award Administration Information

1.
Award Notices

After
the peer review of the application is completed, the applicant organization
will receive a written critique called a “Summary Statement.” The applicant
organization and the PD/PI will be able to access the Summary Statement via the
eRA Commons.

HHS/CDC will contact those
applicants under consideration for funding for additional information.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
Grants Management Officer (GMO) is the authorizing document. HHS/CDC will mail
and/or e-mail this document to the recipient fiscal officer identified in the
application.

Selection of the application for award is not an
authorization to begin performance. Any cost incurred before receipt of the
NoA is at the recipient’s risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section IV.5. Funding
Restrictions.

2. Administrative and National Policy Requirements

The
Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about
requirements. For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
Additional requirements are available in Section VIII. Other Information of
this document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These
will be incorporated into the NoA by reference.

The following terms and conditions will be incorporated
into the NoA and will be provided to the appropriate institutional official and
a courtesy copy to the PD/PI at the time of award.

2.A. Cooperative Agreement

The following terms of award are in addition to, and not
in lieu of, otherwise applicable Office of Management and Budget (OMB)
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS/PHS, and HHS/CDC grant administration policies.

The administrative
and funding instrument used for this program will be the cooperative agreement
U01, an "assistance" instrument (rather than an "acquisition"
instrument), in which substantial HHS/CDC programmatic involvement with the
awardees is anticipated during the performance of the activities. Under the
cooperative agreement, the HHS/CDC purpose is to support and stimulate the
recipients' activities by involvement in and otherwise working jointly with the
award recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the HHS/CDC may share specific tasks and
activities, as defined above.

2.A.1. Recipient Rights and Responsibilities

The
Recipient will have the primary responsibility for the oversight of
all management, administrative, and scientific aspects of the research
including all data, resources, and operations.

The recipient organization will retain custody of and have
primary rights to the information, data and software developed under this
award, subject to U.S. Government rights of access consistent with current HHS,
HHS/PHS, and applicable HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities

An
HHS/CDC Project Scientist will have substantial programmatic involvement that
is above and beyond the normal stewardship role in awards, as described below:

There are
two separate CDC scientific roles – Scientific Collaborator and Scientific
Program Administrator

In this cooperative agreement, a CDC Scientist (Scientific
Collaborator) within the National Center on Birth Defects and Developmental
Disabilities (NCBDDD) is an equal partner with scientific and programmatic
involvement during the conduct of the project through technical assistance,
advice, and coordination.

Scientific Collaborators will:

1. Use their experience in studies of this nature to advise the
project on specific questions regarding the project-developed protocol;

2. As requested, assist the project in responding to inquiries
regarding such areas as data management, data analysis, intervention design,
formats for presenting research findings, and in comparing project-developed
evaluation formats with other research projects and activities known to CDC;

3. Provide scientific consultation and technical assistance as
requested on questions related to epidemiology, statistical and power
calculations, and data storage and tracking formats used in other CDC sponsored
research that could be advantageous to the project; and

4. Suggest to the project upon request processes for analysis,
interpretation, and reporting of findings in the literature that can serve a
broad range of scientific interests.

CDC Scientific Program Administrator (SPA)
The CDC NCBDDD Office of Extramural Research (OER) will appoint an SPA, apart
from the NCBDDD Scientific Collaborator who will:

1. Serve as the Program Official for the funded research
institutions.

2. Carry out continuous review of all activities to ensure
objectives are being met.

3. Provide scientific consultation and technical assistance in the
conduct of the project as requested.

Additionally,
an HHS/CDC agency program official or CIO program director will be responsible
for the normal scientific and programmatic stewardship of the award and will be
named in the Notice of Award.

2.A.3. Collaborative Responsibilities

The planning and implementation of the cooperative
aspects of the study will be effected by a Coordinating Committee consisting of
the Principal Investigator from organizations receiving awards under this
announcement and the CDC Scientific Collaborator; and will address issues of
common concern throughout the life of the project. Organizations serving as
sub-contractors under awarded projects are not considered members of the
Coordinating Committee.

At periodic Coordination Committee meetings
among recipients, the group will: (1) make recommendations on the study
protocol and data collection approaches; (2) discuss common protocols as they
relate to all data; (3) discuss the target populations that have been or will
be recruited; (4) identify and recommend solutions to unexpected study problems;
and (5) discuss ways to efficiently coordinate study activities and best
practices.

Each
full member will have one vote. Awardee members of the Coordinating Committee
(including a CDC member) should accept and implement policies approved by the Committee.
The Committee decisions are used to implement the objectives of the project
activities in a consistent way.

3.
Reporting

The
recipient organization must provide HHS/CDC with an original, plus two hard
copies of the following reports:

2. Financial
status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after
the end of the project period.

The
recipient organization must forward these reports by the U.S. Postal Service or
express delivery to the Grants Management Specialist listed in the “Agency
Contacts” section of this NoA. Progress reports may be made electronically
while Financial status reports should be provided in hard copy format.

Although the financial plans of the HHS/CDC CIO(s) provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds, evidence of satisfactory progress by
the recipient (as documented in required reports) and the determination that
continued funding is in the best interest of the Federal government.

Section
VII. Agency Contacts

HHS/CDC encourages your inquiries
concerning this FOA and welcomes the opportunity to answer questions from
potential applicants. Inquiries can fall into three areas: scientific/research,
peer review, and financial or grants management issues:

Human Subjects ProtectionFederal regulations
(45 CFR Part 46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be
found on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for
Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and
Prevention (CDC) and the Agency for Toxic Substances and Disease Registry
(ATSDR) to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and ethnic
groups are those defined in OMB Directive No. 15 and include American Indian or
Alaska Native, Asian, Black or African American, Hispanic or Latino, Native
Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial
and ethnic minority populations are appropriately represented in applications
for research involving human subjects. Where clear and compelling rationale
exist that inclusion is inappropriate or not feasible, this situation must be
explained as part of the application. This policy does not apply to research
studies when the investigator cannot control the race, ethnicity, and/or sex of
subjects. Further guidance to this policy is contained in the Federal Register,
Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

Inclusion of Persons Under the Age of 21 in Research
The policy of CDC is that persons under the age of 21 must be included in all
human subjects research that is conducted or supported by CDC, unless there are
scientific and ethical reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human subjects, including
research that is otherwise exempt in accordance with Sections 101(b) and 401(b)
of 45 C.F.R. Part 46, HHS Policy for
the Protection of Human Subjects. Therefore, proposals for research involving human
subjects must include a description of plans for including persons under the
age of 21. If persons under the age of 21 will be excluded from the research,
the application or proposal must present an acceptable justification for the
exclusion.

In an extramural research plan, the investigator should create a
section titled "Participation of persons under the age of 21." This
section should provide either a description of the plans to include persons
under the age of 21 and a rationale for selecting or excluding a specific age
range, or an explanation of the reason(s) for excluding persons under the age
of 21 as participants in the research. When persons under the age of 21 are
included, the plan must also include a description of the expertise of the
investigative team for dealing with individuals at the ages included, the
appropriateness of the available facilities to accommodate the included age
groups, and the inclusion of a sufficient number of persons under the age of 21
to contribute to a meaningful analysis relative to the purpose of the study.
Scientific review groups at CDC will assess each application as being
acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion
of persons under the age of 21 in the research project, in addition to
evaluating the plans for conducting the research in accordance with these
provisions.

The inclusion of children (as defined by the applicable law of the
jurisdiction in which the research will be conducted) as subjects in research
must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent
federal laws and regulations.

The policy of inclusion of persons under the age of 21 in
CDC-conducted or CDC-supported research activities in foreign countries
(including collaborative activities) is the same as that for research conducted
in the United States.

Paperwork Reduction Act
Requirements
Under the Paperwork Reduction Act, projects that involve the
collection of information from 10 or more individuals and funded by a grant or
a cooperative agreement will be subject to review and approval by the Office of
Management and Budget (OMB).

Smoke-Free Workplace Requirements

HHS/CDC strongly encourages all
recipients to provide a smoke-free workplace and to promote abstinence from all
tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities that receive Federal funds in which education,
library, day care, health care, or early childhood development services are
provided to children.

Healthy
People 2010

The Public Health Service (PHS) is
committed to achieving the health promotion and disease prevention objectives
of "Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Lobbying
Restrictions

Applicants should be aware of
restrictions on the use of HHS funds for lobbying of Federal or State
legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients
(and their sub-tier contractors) are prohibited from using appropriated Federal
funds (other than profits from a Federal contract) for lobbying congress or any
Federal agency in connection with the award of a particular contract, grant,
cooperative agreement, or loan. This includes grants/cooperative agreements
that, in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.

In addition no part of HHS/CDC appropriated funds, shall
be used, other than for normal and recognized executive-legislative
relationships, for publicity or propaganda purposes, for the preparation,
distribution, or use of any kit, pamphlet, booklet, publication, radio,
television, or video presentation designed to support or defeat legislation
pending before the Congress or any State or local legislature, except in
presentation to the Congress or any State or local legislature itself. No part
of the appropriated funds shall be used to pay the salary or expenses of any
grant or contract recipient, or agent acting for such recipient, related to any
activity designed to influence legislation or appropriations pending before the
Congress or any State or local legislature.

Any activity designed to influence
action in regard to a particular piece of pending legislation would be
considered "lobbying." That is lobbying for or against pending
legislation, as well as indirect or "grass roots" lobbying efforts by
award recipients that are directed at inducing members of the public to contact
their elected representatives at the Federal or State levels to urge support
of, or opposition to, pending legislative proposals is prohibited. As a matter
of policy, HHS/CDC extends the prohibitions to lobbying with respect to local
legislation and local legislative bodies.

The provisions are not intended to
prohibit all interaction with the legislative branch, or to prohibit
educational efforts pertaining to public health. Clearly there are
circumstances when it is advisable and permissible to provide information to
the legislative branch in order to foster implementation of prevention
strategies to promote public health. However, it would not be permissible to
influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use
HHS/CDC funds to engage in activity to enhance prevention; collect and analyze
data; publish and disseminate results of research and surveillance data;
implement prevention strategies; conduct community outreach services; provide
leadership and training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and
cooperative agreements need to be careful to prevent CDC funds from being used
to influence or promote pending legislation. With respect to conferences,
public events, publications, and "grassroots" activities that relate
to specific legislation, recipients of HHS/CDC funds should give close
attention to isolating and separating the appropriate use of HHS/CDC funds from
non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful
not to give the appearance that HHS/CDC funds are being used to carry out
activities in a manner that is prohibited under Federal law.

Accounting System Requirements

The services of a certified
licensed public accountant or the equivalent must be retained throughout the
project as a part of the recipient's staff or as a consultant to the
recipient's accounting personnel. These services may include the design,
implementation, and maintenance of an accounting system that will record
receipts and expenditures of Federal funds in accordance with accounting
principles, Federal regulations, and terms of the cooperative agreement or
grant.

Capability Assessment

It may be necessary to conduct an
on-site evaluation of some applicant organization's financial management
capabilities prior to or immediately following the award of the grant or
cooperative agreement. Independent audit statements from a Certified Public
Accountant (CPA) for the preceding two fiscal years may also be required.

Proof of Non-profit Status

Proof of nonprofit status must be
submitted by private nonprofit organizations with the application. Any of the
following is acceptable evidence of nonprofit status: (a) a reference to the
applicant organization's listing in the Internal Revenue Service's (IRS) most
recent list of tax-exempt organizations described in section 501(c)(3) of the
IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a
statement from a State taxing body, State Attorney General, or other
appropriate State Official certifying that the applicant organization has a
nonprofit status and that none of the net earnings accrue to any private shareholders
or individuals; (d) a certified copy of the organization's certificate of
incorporation or similar document that clearly establishes nonprofit status;
(e) any of the above proof for a State or national parent organization and a
statement signed by the parent organization that the applicant organization is
a local nonprofit affiliate.

Security
Clearance Requirement

All individuals who will be
performing work under a grant or cooperative agreement in a HHS/CDC-owned or
leased facility (on-site facility) must receive a favorable security clearance,
and meet all security requirements. This means that all awardee employees,
fellows, visiting researchers, interns, etc., no matter the duration of their
stay at HHS/CDC must undergo a security clearance process.

Small,
Minority, And Women-Owned Business

It is a national policy to place a
fair share of purchases with small, minority and women-owned business firms.
The Department of Health and Human Services is strongly committed to the
objective of this policy and encourages all recipients of its grants and
cooperative agreements to take affirmative steps to ensure such fairness. In
particular, recipients should:

Place small, minority,
women-owned business firms on bidders mailing lists.

Solicit these firms whenever
they are potential sources of supplies, equipment, construction, or
services.

Where feasible, divide total
requirements into smaller needs, and set delivery schedules that will
encourage participation by these firms.

Use the assistance of the
Minority Business Development Agency of the Department of Commerce, the
Office of Small and Disadvantaged Business Utilization, DHHS, and similar
state and local offices.

Research
Integrity

The signature of the institution
official on the face page of the application submitted under this Funding
Opportunity Announcement is certifying compliance with the Department of Health
and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E,
entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

Section 93.301 Institutional assurances.(a) General
policy. An institution with PHS supported biomedical or behavioral research,
research training or activities related to that research or research training
must provide PHS with an assurance of compliance with this part, satisfactory
to the Secretary. PHS funding components may authorize [[Page 28389]] funds for
biomedical and behavioral research, research training, or activities related to
that research or research training only to institutions that have approved
assurances and required renewals on file with ORI. (b) Institutional Assurance.
The responsible institutional official must assure on behalf of the institution
that the institution-- (1) Has written policies and procedures in compliance
with this part for inquiring into and investigating allegations of research
misconduct; and (2) Complies with its own policies and procedures and the
requirements of this part.

Compliance with Executive Order 13279

Faith-based organization are eligible to receive federal
financial assistance, and their applications are evaluated in the same manner
and using the same criteria as those for non-faith-based organizations in
accordance with Executive Order 13279, Equal Protection of the Laws for
Faith-Based and Community Organizations. All applicants should, however, be
aware of restrictions on the use of direct financial assistance from the
Department of Health and Human Services (DHHS) for inherently religious
activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96,
organizations that receive direct financial assistance from DHHS under any DHHS
program may not engage in inherently religious activities, such as worship,
religious instruction, or proselytization as a part of the programs or services
funded with direct financial assistance from DHHS. If an organization engages
in such activities, it must offer them separately, in time or location, from
the programs or services funded with direct DHHS assistance, and participation
must be voluntary for the beneficiaries of the programs or services funded with
such assistance. A religious organization that participates in the DHHS funded
programs or services will retain its independence from Federal, State, and
local governments, and may continue to carry out its mission, including the
definition, practice, and expression of its religious beliefs, provided that it
does not use direct financial assistance from DHHS to support inherently
religious activities such as those activities described above. A faith-based
organization may, however, use space in its facilities to provide programs or
services funded with financial assistance from DHHS without removing religious
art, icons, scriptures, or other religious symbols. In addition, a religious
organization that receives financial assistance from DHHS retains its authority
over its internal governance, and it may retain religious terms in its
organization=s name, select its board members on a religious basis, and
include religious references in its organization=s mission
statements and other governing documents in accordance with all program
requirements, statutes, and other applicable requirements governing the conduct
of DHHS funded activities. For further guidance on the use of DHHS direct
financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal
Treatment for Faith-Based Organizations, and visit the internet site:http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and
Accountability Act Requirements

Recipients of this grant award
should note that pursuant to the Standards for Privacy of Individually
Identifiable Health Information promulgated under the Health Insurance Portability
and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may
disclose protected health information to public health authorities authorized
by law to collect or receive such information for the purpose of preventing or
controlling disease, injury, or disability, including, but not limited to, the
reporting of disease, injury, vital events such as birth or death, and the
conduct of public health surveillance, public health investigations, and public
health interventions. The definition of a public health authority includes a
person or entity acting under a grant of authority from or contract with such
public agency. HHS/CDC considers this project a public health activity
consistent with the Standards for Privacy of Individually Identifiable Health
Information and HHS/CDC will provide successful recipients a specific grant of
public health authority for the purposes of this project.

Release and Sharing of Data
The Data Release Plan is the
Grantee's assurance that the dissemination of any and all data collected under
the HHS/CDC data sharing agreement will be released as follows:

In a timely manner.

Completely, and as accurately
as possible.

To facilitate the broader
community.

Developed in accordance with
CDC policy on Releasing and Sharing Data.

Applications
must include a copy of the applicant's Data Release Plan. Applicants
should provide HHS/CDC with appropriate documentation on the reliability of the
data. Applications submitted without the required Plan may be ineligible
for award. Award will be made when reviewing officials have approved an
acceptable Plan. The successful applicant and the Program Manager will
determine the documentation format. HHS/CDC recommends data is released
in the form closest to micro data and one that will preserve
confidentiality.

National Historic
Preservation Act of 1966

(Public Law 89-665, 80
Stat. 915)

The grantee’s signature
on the grant application attests to their: (1) knowledge of the National
Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2)
intent to ensure all grant related activities are in compliance with referenced
public law, as stated:

The
head of any Federal agency, having direct or indirect jurisdiction over a
proposed Federal or Federally assisted undertaking in any State and the head of
any Federal department or independent state agency having authority to license
any undertaking, shall, prior to the approval of the expenditure of any
Federal funds on the undertaking or prior to the issuance of any license, as
the case may be, take into account the effect of the undertaking on any
district, site, building, structure, or object that is included in or is
eligible for inclusion in the National Register. The head of any such Federal
agency shall afford the Advisory Council on Historic Preservation established under
Title II of this ACT a reasonable opportunity to comment with regard to such
undertaking.

b. Additionally,
the NHPA also contains the following excerpt that forbids “anticipatory
demolition:”

Each
Federal agency shall ensure that the agency will not grant a loan, loan
guarantee, permit, license, or other assistance to an applicant who, with
intent to avoid the requirements of Section 106 of this Act, has intentionally,
significantly, adversely affected a historic property to which the grant would
relate or, having legal power to prevent it, allowed such significant adverse
effect to occur, unless the agency, after consultation with the Council,
determines that circumstances justify granting such assistance despite the
adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of
Logos

Disclaimer: Where a conference is funded by a grant or cooperative
agreement, a subgrant or a contract the recipient must include the following
statement on conference materials, including promotional materials, agenda, and
internet sites:

“Funding for this conference was made possible [in part]
by [insert grant or cooperative agreement award number] from the Centers for
Disease Control and Prevention(CDC) or the Agency for Toxic Substances and
Disease Registry (ATSDR) . The views expressed in written conference materials
or publications and by speakers and moderators do not necessarily reflect the
official policies of the Department of Health and Human Services; nor does
mention of trade names, commercial practices, or organizations imply
endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be
displayed if such display would cause confusion as to the source of the
conference or give the false appearance of Government endorsement. A
non-federal entity’s unauthorized use of the HHS name or logo is governed by
U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in
written communication. The appropriate use of the HHS logo is subject to the
review and approval of the Office of the Assistant Secretary for Public Affairs
(OASPA). Moreover, the Office of the Inspector General has authority to impose
civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS
nor the CDC logo can be used on conference materials under a grant, cooperative
agreement, contract or co-sponsorship agreement without the expressed, written
consent of either the Project Officer or the Grants Management Officer. It is
the responsibility of the grantee (or recipient of funds under a cooperative
agreement) to request consent for the use of the logo in sufficient detail to
assure a complete depiction and disclosure of all uses of the Government logos,
and to assure that in all cases of the use of Government logos, the written
consent of either the Project Officer or the Grants Management Officer has been
received.